(127 days)
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
PANAVIA SA Cement Universal is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations. It has a choice of Automix delivery (equal amounts of two components are combined through a mixing tip) or Handmix (equal amount of two components are combined on a mixing pad).
This document describes the premarket notification for the PANAVIA SA Cement Universal dental cement.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally based on compliance with ISO 4049:2009 (Dentistry - Polymer-based restorative and materials) and a comparative study against a predicate device.
| Acceptance Criteria (ISO 4049:2009 Sections) | Reported Device Performance (PANAVIA SA Cement Universal - Handmix) | Predicate Device Performance (PANAVIA SA Cement Plus Automix) |
|---|---|---|
| 5.2.2 Film thickness, luting materials | COMPLIES | COMPLIES |
| 5.2.4 Working time, Class 1 and Class 3 luting materials | COMPLIES | COMPLIES |
| 5.2.6 Setting time, Class 3 materials | COMPLIES | COMPLIES |
| 5.2.9 Flexural strength | COMPLIES | COMPLIES |
| 5.2.10 Water sorption | COMPLIES | COMPLIES |
| 5.2.10 Solubility | COMPLIES | COMPLIES |
| 5.4 Color stability after irradiation and water sorption | COMPLIES | COMPLIES |
| 5.5 Radio-opacity | COMPLIES | COMPLIES |
| Bond Strength to Tooth dentin | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Tooth enamel | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Ceramic | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Metal | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Titan | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Composite resin | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Bond Strength to Amalgam | COMPLIES (In-house standard) | COMPLIES (In-house standard) |
| Released fluorine ion | Substantially equivalent to predicate | Predicate performance |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test in the comparative study (e.g., number of samples for film thickness, strength, bond strength measurements).
The data provenance is from non-clinical testing performed by the manufacturer, Kuraray Noritake Dental Inc., in Japan. The studies are retrospective in the sense that they are laboratory tests conducted to compare the new device against an already marketed predicate device, rather than a clinical trial with human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is a non-clinical, laboratory-based study comparing a new dental cement to a predicate device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical diagnostics or image interpretation does not directly apply. The "ground truth" for these tests is established by adherence to the specifications and methodologies outlined in ISO 4049:2009 for physical and mechanical properties, and internal standards for bond strength. The expertise lies in the laboratory technicians and scientists performing and evaluating these standardized tests. No specific number or qualifications of "experts" are listed for establishing ground truth in this context.
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as this is a non-clinical laboratory study, not a study evaluating human interpretation of data. The results are obtained through standardized measurements and comparisons.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically used for medical imaging devices where human readers interpret images. This document describes a dental cement, and its evaluation focuses on physical, mechanical, and chemical properties, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. PANAVIA SA Cement Universal is a dental cement, not an algorithm or a device requiring human-in-the-loop performance in the context of AI. The performance is the inherent material properties of the cement.
7. Type of Ground Truth Used:
The ground truth used for performance validation is:
- International standards: Specifically, compliance with the requirements outlined in ISO 4049:2009 (Dentistry - Polymer-based restorative and materials) for various physical and mechanical properties.
- Comparative equivalence to a legally marketed predicate device: The subject device's performance (bond strength, fluorine ion release) was compared directly to PANAVIA SA Cement Plus Automix, demonstrating non-inferiority or substantial equivalence.
- In-house standards: For bond strength tests, "In-house standard" was used for assessment.
8. Sample Size for the Training Set:
Not applicable. This is a dental material, not a machine learning algorithm that requires a training set. The term "training set" is typically used in the context of artificial intelligence/machine learning model development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a dental cement product.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.